FDA Part 11 | Validating Electronic Data

FDA Part 11 refers to Title 21 CFR Part 11 that seeks to define when electronic signatures and records are as reliable and trustworthy as their paper equivalents. Most businesses that deal with the FDA are bound by the standards set by FDA Part 11.
For businesses within or that deal with the following industries, you must work to maintain compliance:
  • Healthcare
  • Drug and medical equipment manufacturers
  • Biotechnology
  • Medical records

Choosing The Right Solutions

There are a wide variety of solutions used to manage electronic records and ensure their integrity. However, it’s vital to use a solution that meets all the criteria to maintain compliance. Any system a business chooses to use must meet the following standards:
  • Options for signature manifestations
  • Ability to link records to signatures
  • Include controls for both closed and open systems
  • Include options for secure user identification codes and passwords
  • Controls for electronic signature components
Any signatures on records must be either digital or electronic. Electronic signatures can be a combination of symbols that are authorized by a user and are as legally binding as a physical signature. A digital signature is a type of electronic signature created using cryptographic methods. The purpose is to be able to verify the identity of the signer.

Maintaining FDA Part 11 compliance is sometimes tricky, but it doesn’t have to be when you have the right IT outsourcing partner. From ensuring you use compliant systems to performing compliance audits, ISOutsource has you covered. Contact us to learn more today.